Surgery
This section discusses the importance of anticoagulation therapy for patients with prosthetic valves and examines the current guideline recommendations, current evidence for, and ongoing studies on, the use of NOACs in these patients
In this section:
Importance of anticoagulation therapy for patients with prosthetic valve
Thromboembolism and anticoagulant-related bleeding represent the majority of complications experienced by prosthetic valve recipients.1 The need for chronic anticoagulation therapy as a result of AF accompanying valvular heart disease highlights the importance of optimizing the quality of anticoagulation care to minimize postoperative thromboembolic complications, while maintaining an acceptable risk profile.2
Current guideline recommendations for patients with prosthetic valves
After valve repair with a mechanical or bioprosthetic device, VKA therapy is indicated for the prevention of stroke and systemic embolism; American College of Chest Physicians (ACCP)3 and American College of Cardiology (ACC)/American Heart Association (AHA)4,5 guidelines provide recommendations based on the type and position of valve replacement (summarized in Figure) due to the differing associated risk of thromboembolic events:
- Bioprostheses: recommended for patients irrespective of age for whom anticoagulant therapy is contraindicated, cannot be managed, or is not desired4
- Mechanical prostheses: for aortic valve replacement or mitral valve replacement in patients <60 years of age without contraindications to anticoagulation4
- Mechanical valves in the mitral position: generally more thrombogenic than those in the aortic position3
Antithrombotic prophylaxis for recipients of prosthetic valves4
Current evidence with NOACs for patients with prosthetic valves
To date, only one clinical trial – the phase II RE-ALIGN trial – assessed the performance of an NOAC (dabigatran; N=37) versus warfarin (N=22) in patients with a mechanical heart valve. There was an increased rate of thromboembolic and bleeding complications associated with dabigatran versus warfarin that resulted in the trial being terminated prematurely.6
The role of NOACs in patients with prosthetic valves requires further research; two phase II clinical trials have investigated the efficacy and safety of rivaroxaban for the prevention of major complications in patients undergoing mechanical aortic valve replacement (CATHAR trial; ClinicalTrials.gov NCT02128841)7 and explored how rivaroxaban compared with VKA therapy in patients with AF with bioprosthetic mitral valves (RIVER trial; ClinicalTrials.gov NCT02303795).8 The RIVER trial is currently ongoing.9 However, the CATHAR trial has been terminated due to poor patient recruitment.
Multicentre, open-label, randomized trials investigating the use of NOACs compared with standard treatment strategies in patients after transcatheter aortic valve replacement are currently ongoing. These include the GALILEO trial (ClinicalTrials.gov NCT02556203)10 and the ATLANTIS trial (ClinicalTrials.gov NCT02664649).11 The GALILEO trial, a global trial, comparing rivaroxaban-based antithrombotic therapy to an antiplatelet strategy consisting of ASA and clopidogrel was terminated prematurely due to safety concerns.12 The ATLANTIS trial, a phase IIIb trial, aims to demonstrate the superiority of apixaban compared with VKA or antiplatelet therapy and is ongoing.13
References
- Baumgartner H, Falk V, Bax J et al. 2017 ESC/EACTS guidelines for the management of valvular heart disease. Eur Heart J 2017;38:2739–2791. Return to content
- Carnicelli A. Anticoagulation for valvular heart disease. 2015. Available at: http://www.acc.org/latest-in-cardiology/articles/2015/05/18/09/58/anticoagulation-for-valvular-heart-disease [accessed 20 November 2020]. Carnicelli A. Anticoagulation for valvular heart disease. 2015. Available at: http://www.acc.org/latest-in-cardiology/articles/2015/05/18/09/58/anticoagulation-for-valvular-heart-disease [accessed 20 November 2020]. Return to content
- Whitlock RP, Sun JC, Fremes SE et al. Antithrombotic and thrombolytic therapy for valvular disease: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 2012;141:e576S–e600S. Return to content
- Nishimura RA, Otto CM, Bonow RO et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2014;63:2438–2488. Return to content
- Nishimura RA, Otto CM, Bonow RO et al. 2017 AHA/ACC focused update of the 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol 2017;70:252–289. Return to content
- Eikelboom JW, Connolly SJ, Brueckmann M et al. Dabigatran versus warfarin in patients with mechanical heart valves. N Engl J Med 2013;369:1206–1214. Return to content
- University Hospital Inselspital B. Comparison of Antithrombotic Treatments After Aortic Valve Replacement. Rivaroxaban: A New Antithrombotic Treatment for Patients With Mechanical Prosthetic Aortic Heart Valve (CATHAR). 2017. Available at: https://clinicaltrials.gov/ct2/show/NCT02128841 [accessed 20 November 2020]. University Hospital Inselspital B. Comparison of Antithrombotic Treatments After Aortic Valve Replacement. Rivaroxaban: A New Antithrombotic Treatment for Patients With Mechanical Prosthetic Aortic Heart Valve (CATHAR). 2017. Available at: https://clinicaltrials.gov/ct2/show/NCT02128841 [accessed 20 November 2020]. Return to content
- Hospital do Coracao. Rivaroxaban for valvular heart disease and atrial fibrillation trial (RIVER). 2019. Available at: https://clinicaltrials.gov/ct2/show/record/NCT02303795 [accessed 20 November 2020]. Hospital do Coracao. Rivaroxaban for valvular heart disease and atrial fibrillation trial (RIVER). 2019. Available at: https://clinicaltrials.gov/ct2/show/record/NCT02303795 [accessed 20 November 2020]. Return to content
- Guimaraes HP, de Barros ESPGM, Liporace IL et al. A randomized clinical trial to evaluate the efficacy and safety of rivaroxaban in patients with bioprosthetic mitral valve and atrial fibrillation or flutter: Rationale and design of the RIVER trial. Am Heart J 2020: doi:10.1016/j.ahj.2020.10.001. Guimaraes HP, de Barros ESPGM, Liporace IL et al. A randomized clinical trial to evaluate the efficacy and safety of rivaroxaban in patients with bioprosthetic mitral valve and atrial fibrillation or flutter: Rationale and design of the RIVER trial. Am Heart J 2020: doi:10.1016/j.ahj.2020.10.001. Return to content
- Windecker S, Tijssen J, Giustino G et al. Trial design: Rivaroxaban for the prevention of major cardiovascular events after transcatheter aortic valve replacement: Rationale and design of the GALILEO study. Am Heart J 2017;184:81–87. Windecker S, Tijssen J, Giustino G et al. Trial design: Rivaroxaban for the prevention of major cardiovascular events after transcatheter aortic valve replacement: Rationale and design of the GALILEO study. Am Heart J 2017;184:81–87. Return to content
- Assistance Publique - Hôpitaux de Paris, Action Research Group, Bristol-Myers Squibb & Pfizer. Anti-thrombotic strategy after trans-aortic valve implantation for aortic stenosis (ATLANTIS). 2019. Available at: https://clinicaltrials.gov/ct2/show/study/NCT02664649 [accessed 20 November 2020]. Assistance Publique - Hôpitaux de Paris, Action Research Group, Bristol-Myers Squibb & Pfizer. Anti-thrombotic strategy after trans-aortic valve implantation for aortic stenosis (ATLANTIS). 2019. Available at: https://clinicaltrials.gov/ct2/show/study/NCT02664649 [accessed 20 November 2020]. Return to content
- Dangas GD, Tijssen JGP, Wohrle J et al. A controlled trial of rivaroxaban after transcatheter aortic-valve replacement. N Engl J Med 2020;382:120–129. Dangas GD, Tijssen JGP, Wohrle J et al. A controlled trial of rivaroxaban after transcatheter aortic-valve replacement. N Engl J Med 2020;382:120–129. Return to content
- Collet JP, Berti S, Cequier A et al. Oral anti-Xa anticoagulation after trans-aortic valve implantation for aortic stenosis: The randomized ATLANTIS trial. Am Heart J 2018;200:44–50. Collet JP, Berti S, Cequier A et al. Oral anti-Xa anticoagulation after trans-aortic valve implantation for aortic stenosis: The randomized ATLANTIS trial. Am Heart J 2018;200:44–50. Return to content
See Also
Peripheral Artery Disease: causes and consequences
See Also
Coronary Artery Disease: causes and consequences
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